1. Field
The present application generally relates to devices and methods for locating the proper position to perform a cardiac procedure and/or capturing embolic debris during a cardiac procedure.
2. Description of the Related Art
During percutaneous cardiac procedures, precise positioning of various instruments and devices can be important. For example, when performing a percutaneous valve replacement procedure, the valve is generally placed no more than 4-6 millimeters (mm) below the lower border of the aortic annulus. Placing the valve prosthesis too low or too high can result in severe leaking of the valve, which in some cases can be fatal. Therefore, it can be important to identify the lower border of the annulus to use as a reference point. A pigtail catheter may be used to inject a contrast agent to allow for visualization for proper positioning. Pigtail catheters may include a coiled distal portion and a plurality of small holes in the catheter side walls. The small holes allow for the introduction of contrast materials into the body for imaging purposes or drainage of fluids from the body. The coiled distal portion helps hold the catheter is place and can slow the flow of contrast fluids from the catheter lumen to avoid causing internal injuries or poor imaging results.
A potential complication of cardiac procedures such as valve replacement and repair is that plaque, calcium, and/or thrombi in the vessels, valves, and/or cardiac chambers can be dislodged and cause an embolism. Indeed, 2.9%-6.7% of patients undergoing transfemroal transcatheter aortic-valve implantation (TAVI) have a stroke within 30 days, and even more (4.5%-10.6%) have a stroke within a year, often leading to death. There are a few devices on the market designed to protect the carotid arteries from emboli; however, these devices have various disadvantages. For example, the Embrella Embolic Deflector®, available from Edwards Lifesciences of Irvine, Calif., deflects emboli from the carotid arteries into the descending aorta, but does not trap the emboli, so there is a risk of embolisms in other areas of the body. The EMBOL-X®, also available from Edwards Lifesciences, employs a filtering screen, but it is designed for use in open heart procedures. Additionally, the use of multiple devices, for example a catheter for visualization and a separate filter device, lengthens the procedure time and increases the risk of complications to the patient.